Profile Altering Tip for a Delivery System

ABSTRACT

A profile altering tip is provided for a delivery system. The tip defines a first profile with a generally conical shape and a second profile with a generally round shape. During use of the delivery system, a tip profile control assembly can alter the tip from the first profile to the second profile.

BACKGROUND

Diseased or otherwise deficient heart valves can be repaired or replaced with an implanted prosthetic heart valve. Conventionally, heart valve replacement surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. Traditional open surgery inflicts significant patient trauma and discomfort, and exposes the patient to a number of potential risks, such as infection, stroke, renal failure, and adverse effects associated with the use of the heart-lung bypass machine, for example.

Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. With these percutaneous transcatheter (or transluminal) techniques, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the annulus of the valve to be repaired (e.g., the aortic valve annulus). In order to access an implantation site for the valve, a tip is positioned at a distal end of the delivery system to facilitate delivery to the implantation site. In some instances, the tip can cause inadvertent injury to a patient during implantation of the valve.

SUMMARY

One aspect of concepts presented herein relates to a device component for a delivery system. The component includes an elongate member extending from a proximal end to a distal end. A tip is coupled with the distal end of the elongate member and transitions, in response to an axially applied force applied to the elongate member, from a first, conical profile to a second, rounded profile.

Another aspect relates to a delivery system for a stent frame. The delivery system includes a retention member having a coupling structure configured to couple the stent frame to the retention member and a tip positioned distal the coupling structure. A capsule is configured to maintain the stent frame in a compressed arrangement. A tip profile control assembly includes an elongate member coupled with the tip. The elongate member extends from a proximal end to a distal end. The tip includes a tip end and a base end opposite the tip end, the elongate member transitioning the tip end from a first profile to a second profile based on a relative position of the elongate member with respect to the base end.

Yet a further aspect relates to a method of deploying a prosthetic heart valve to an implantation site. The method includes receiving a delivery system having a proximal handle and a distal tip, the system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached. The delivery system includes a delivery sheath capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly. The method further includes delivering the prosthetic heart valve in the compressed arrangement through a native valve of the patient and to the implantation site via the delivery system while the tip defines a first, tapered profile. The tip is transitioned from the first profile to a second, rounded profile. A position of the delivery sheath capsule is adjusted such that the prosthetic heart valve can expand to an expanded arrangement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an exploded, perspective view of a delivery system.

FIG. 1B is a side view of an alternative delivery system.

FIG. 2A is a schematic side view of a tip of the delivery system illustrated in FIG. 1 in a first profile.

FIG. 2B is a schematic sectional view of the tip illustrated in FIG. 2A in the first profile.

FIG. 3A is a schematic side view of the tip of the delivery system illustrated in FIG. 1 in a second profile, different from the first profile.

FIG. 3B is a schematic sectional view of the tip illustrated in FIG. 3A in the second profile.

DETAILED DESCRIPTION

As referred to herein, a prosthetic heart valve as used in accordance with the various systems, devices, and methods of the present disclosure may include a wide variety of different configurations, such as a bioprosthetic heart valve having tissue leaflets or a synthetic heart valve having a polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. Thus, the prosthetic heart valve useful with the systems, devices, and methods of the present disclosure can be generally used for replacement of a native aortic, mitral, pulmonic, or tricuspid valves, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example.

In general terms, the prosthetic heart valves of the present disclosure include a frame maintaining a valve structure (tissue or synthetic), with the frame having a normal, expanded arrangement and collapsible to a compressed arrangement for loading within the delivery system. The frame is normally constructed to self-deploy or self-expand when released from the delivery system. A variety of materials can be used to form the frame, including metals (e.g., stainless steel, gold, titanium, titanium alloys) and polymers (e.g., silicone, polyethylene, polyurethane). Although embodiments discussed below reference prosthetic heart valves, concepts presented herein can be utilized with stent frames that do not have an attached valve structure (e.g., coronary stents, biliary stents).

With the above in mind, one embodiment of a transcatheter stented prosthetic heart valve delivery system 30 is shown in FIG. 1A. Although herein disclosed as applicable to a prosthetic heart valve, system 30, as well as other embodiments disclosed herein, can be used with other delivery systems, such as those utilized for stent delivery without an attached valve structure. The system 30 generally includes an inner shaft assembly 34, a delivery sheath assembly 36, and a handle 38. Details on the various components are provided below. In general terms, however, the delivery system 30 provides a loaded state in which a stent frame (not shown) is coupled to the inner shaft assembly 34 and compressively retained within a capsule 40 of the delivery sheath assembly 36. The delivery sheath assembly 36 can be manipulated to withdraw the capsule 40 proximally from the prosthetic heart valve via operation of the handle 38, permitting the frame to self-expand and release from the inner shaft assembly 34.

As a point of reference, various features of the components 34-38 reflected in FIG. 1 and described below can be modified or replaced with differing structures and/or mechanisms. Thus, the present disclosure is in no way limited to the inner shaft assembly 34, the delivery sheath assembly 36, the handle 38, etc., as shown and described below. More generally, delivery systems in accordance with the present disclosure provide features capable of compressively retaining a self-deploying, stent frame (e.g., the capsule 40) and a mechanism capable of effectuating release or deployment of the frame (e.g., retracting the capsule 40).

The components 34-38 of the delivery system 30 can assume a variety of forms appropriate for percutaneously delivering and deploying a stent stent frame such as a self-expanding prosthetic heart valve. For example, the inner shaft assembly 34 can have various constructions appropriate for supporting a stented prosthetic heart valve within the capsule 40. In some embodiments, the inner shaft assembly 34 can include a retention member 100, an intermediate tube 102, and a proximal tube 104. In general terms, the retention member 100 can be akin to a plunger, and incorporates features for retaining the stented prosthetic heart valve within the capsule 40 as described below. The tube 102 connects the retention member 100 to the proximal tube 104, with the proximal tube 104, in turn, coupling the inner shaft assembly 34 with the handle 38. The components 100-104 can combine to define a continuous lumen 106 (referenced generally) sized to slidably receive an auxiliary component such as a guide wire (not shown) and a tip profile control assembly 108 coupled with the retention member 100.

The retention member 100 can include a tip 110, a support tube 112, and a hub 114. The assembly 108 can be of various constructions as will be discussed in more detail below. In general, the assembly 108 can include an elongate member, a fixed member and an adjustment member that are used to alter a profile (i.e., shape) of the tip 110. The tip 110 forms or defines multiple profiles as controlled by the tip profile control assembly 108. For example, in a first profile, the tip 110 defines a nose cone having a distally tapering outer surface adapted to facilitate delivery of the capsule 40 through a patient's body to an implantation site. In particular, the tip 110 in the first profile can facilitate dilation of the implantation site (e.g., through vessels) and delivery through a native valve to be replaced (known as “valve crossing”). In a second profile, the tip 110 defines a bulbous or round shape that is atraumatic to an internal anatomy of the patient. The second profile can be utilized for example retraction of the capsule 40 to expose the valve and retraction of the delivery system 30. The tip 110 can further be fixed or slidable relative to the support tube 112.

The support tube 112 extends proximally from the tip 110 and is configured to internally support a compressed, stented prosthetic heart valve generally disposed thereover, and has a length and outer diameter corresponding with dimensional attributes of the selected prosthetic heart valve. The hub 114 is attached to the support tube 112 opposite the tip 110 (e.g., an adhesive bond), and provides a coupling structure 120 (referenced generally) configured to selectively capture a corresponding feature of the prosthetic heart valve. The coupling structure 120 can assume various forms, and is generally located along an intermediate portion of the inner shaft assembly 34. In some constructions, the coupling structure 120 includes one or more fingers sized to be received within corresponding apertures formed by the prosthetic heart valve stent frame (e.g., the prosthetic heart valve stent frame can form wire loops at a proximal end thereof that are received over respective ones of the fingers when compressed within the capsule 40).

The intermediate tube 102 is formed of a flexible polymer material (e.g., PEEK), and is sized to be slidably received within the delivery sheath assembly 36. The proximal tube 104 can include, in some embodiments, a leading portion 122 and a trailing portion 124. The leading portion 122 serves as a transition between the intermediate and proximal tubes 102, 104 and thus in some embodiments is a flexible polymer tubing (e.g., PEEK) having a diameter slightly less than that of the intermediate tube 102. The trailing portion 124 has a more rigid construction, configured for robust assembly with the handle 38 such as a metal hypotube. Other constructions are also envisioned. For example, in other embodiments, the intermediate and proximal tubes 102, 104 are integrally formed as a single, homogenous tube or solid shaft.

The delivery sheath assembly 36 includes the capsule 40 and a delivery sheath shaft 130, and defines proximal and distal ends 132, 134. The capsule 40 extends distally from the delivery shaft 130, and in some embodiments has a more stiffened construction (as compared to a stiffness of the delivery shaft 130) that exhibits sufficient radial or circumferential rigidity to overtly resist the expected expansive forces of the stented prosthetic heart valve in the compressed arrangement. For example, the delivery shaft 130 can be a polymer tube embedded with a metal braiding, whereas the capsule 40 is a laser-cut metal tube. Alternatively, the capsule 40 and the delivery shaft 130 can have a more uniform construction (e.g., a continuous polymer tube). Regardless, the capsule 40 is constructed to compressively retain the stented prosthetic heart valve at a predetermined diameter when loaded within the capsule 40, and the delivery shaft 130 serves to connect the capsule 40 with the handle 38. The delivery shaft 130 (as well as the capsule 40) is constructed to be sufficiently flexible for passage through a patient's vasculature, yet exhibit sufficient longitudinal rigidity to effectuate desired axial movement of the capsule 40. In other words, proximal retraction of the delivery shaft 130 is directly transferred to the capsule 40 and causes a corresponding proximal retraction of the capsule 40. In other embodiments, the delivery shaft 130 is further configured to transmit a rotational force or movement onto the capsule 40.

The handle 38 generally includes a housing 140 and one or more actuator mechanisms 142 (referenced generally). The housing 140 maintains the actuator mechanism(s) 142, with the handle 38 configured to facilitate sliding movement of the delivery sheath assembly 36 relative to the inner shaft assembly 34, as well as alter the profile of tip 110 as controlled by the tip profile control assembly 108. The housing 140 can have any shape or size appropriate for convenient handling by a user. In one simplified construction, a first, deployment actuator mechanism 142 a includes a user interface or actuator 144 slidably retained by the housing 140 and coupled to a delivery sheath connector body 146. The proximal end 132 of the delivery sheath assembly 36 is connected to the delivery sheath connector body 146. The inner shaft assembly 34, and in particular the proximal tube 104, is slidably received within a passage 148 (referenced generally) of the delivery sheath connector body 146, and is rigidly coupled to the housing 140. A second, profile actuator mechanism 142 b (referenced generally) similarly includes a user interface or actuator 150 moveably maintained by the housing 140 and coupled to the tip profile control assembly 108. With this but one acceptable construction, the deployment actuator 144 can be operated to effectuate axial movement of the delivery sheath assembly 36 relative to the inner shaft assembly 34. Similarly, the profile actuator 150 can be manipulated to alter the profile of tip 110 during an implantation procedure.

FIG. 1B is an alternative delivery system 160, which can include several components similar to delivery system 30 as discussed above with respect to FIG. 1A. The system 160 includes a handle 162 at a proximal end and a retention member 164 and delivery sheath capsule 166 at a distal end. The retention member 164 includes distal tip 110 and coupling structure 120 (not show in FIG. 1B) as discussed above. The delivery sheath capsule 166 includes a distal capsule portion 168 and a proximal capsule portion 170 positioned over the retention member 164 to compressively retain a stent frame of a prosthetic heart valve. A first actuator 172 on handle 162 can be operated to position distal capsule portion 168 with respect to proximal capsule portion 170, thus, allowing expansion of a portion (e.g., a distal portion) of the prosthetic heart valve. In a similar manner, an actuator 174 can be operated to position proximal capsule portion 170 with respect to distal capsule portion 168, thus allowing expansion of another portion (e.g., a proximal portion) of the prosthetic heart valve. In one embodiment, during implantation, the proximal capsule portion 170 is positioned to release a portion of the prosthetic heart valve on a first side of a native valve while the distal capsule portion 168 is positioned to release a portion of the prosthetic heart valve on an opposite side of the native valve. Similar to delivery system 30, handle 162 further maintains tip profile control actuator 150 for altering the profile of tip 110, as discussed in more detail below.

FIGS. 2A and 2B illustrate close-up, schematic views of tip 110 in a first profile 200. The tip 110 is positioned distal the capsule 40. The first profile 200 is a generally conical shape, equipped to facilitate delivery of the tip 110 through a patient's anatomy and facilitate dilation of an implantation site. FIGS. 3A and 3B illustrate close-up, schematic views of tip 110 in a second profile 202. The second profile 202 is a generally round or bulbous shape, equipped to form an atraumatic shape suitable for deploying a valve within capsule 40 and retracting the tip 110 after implantation of the valve. As discussed above with respect to FIGS. 1A and 1B, a user can operate the profile actuator 150 such that the tip profile control assembly 108 operates to alter the profile of the tip 110 between the first profile 200 and the second profile 202. In one embodiment, the tip 110 is formed of a polymeric material in a natural arrangement when in the first profile 202 and in a compressed arrangement when in the second profile 202.

The assembly 108 includes an elongate member 204, a fixed member 206 and an adjustment member 208. The elongate member 204 in one embodiment comprises a shaft or wire coupled to profile actuator 150 at a proximal end and extending from the housing 140 to a distal end coupled with the adjustment member 208. The elongate member 204 and adjustment member 208 are movable with respect to the fixed member 206. By providing an axial, pulling force on the elongate member 204 (e.g., by operating profile actuator 150), the elongate member 204 and the adjustment member 208 move in an axial direction with respect to the fixed member 206, compressing the tip 110. In an alternative embodiment, an axial, pushing force on the elongate member 204 can be used to alter the shape of the tip 110, for example by locating fixed member 206 distal the adjustment member 208. When the tip 110 is in the first profile 200 as illustrated in FIGS. 2A and 2B, the adjustment member 208 is positioned a further distance away from fixed member 206 than when the tip is in the second profile 202.

The tip 110, in one embodiment, is formed of a compressible polymer. One example polymer is sold under the tradename PEBAX®, which can be formed of a thermoplastic elastomer exhibiting a low hardness or durometer (e.g., having a hardness durometer of 75 Shore A). Other materials for tip 110 include silicone, Santoprene™, available from ExxonMobil Corporation, and/or combinations of various materials such as one or more of elastomers, rubbers, polymers. The tip 110, in one embodiment, is a polymer formed of a solid, homogenous structure capable of compression. Alternatively, the tip 110 can include a void or cut-out section so as to achieve a desired level of compressibility of the tip 110. The tip 110 extends from a proximal, base end 210 positioned adjacent the capsule 40 to a distal, tip end 212 where the tip 110 terminates. In the first profile 200, the tip 110 is in a natural arrangement that tapers from the base end 210 to the tip end 212. In contrast, in the second profile 202, the tip 110 is in a compressed arrangement that expands outwardly from the base end 210, forming a round shape that is less susceptible to causing injury to a patient's anatomy.

A length L₁ of the tip 110 in the first profile 200 can be defined as a distance from the base end 210 to the tip end 212. In a similar manner, a length L₂ of the tip 110 in the second profile 202 can also be defined as the distance from the base end 210 to the tip end. As will be appreciated, the length L₁ in the first profile 200 is greater than the length L₂ in the second profile 202. In one embodiment, a measurement of L₂ is approximately 50% of a measurement of L₁. In other embodiments, the measurement of L₂ can be in a range from 10% to 90% (e.g., 10%, 25%, 40%, 60%, 75%, 90%) of the measurement of L₁. A width W₁ of the tip 110 in the first profile 200 can be defined as a maximum distance of the tip 110 in a direction orthogonal to the length L₁. In profile 200, the width W₁ is equal (or approximately equal) to a corresponding width of the capsule 40. In other embodiments, the width W₁ can be greater or less than the width of the capsule 40. A width W₂ of the tip 110 in the second profile 202 can be defined as a maximum distance of the tip 110 in a direction orthogonal to the length L₂. In profile W₂, the width is greater than a corresponding width of the capsule 40. In other embodiments, the width W₂ can be equal to or less than the corresponding width of the capsule 40. In the embodiment illustrated, width W₂ in profile 202 is greater than width W₁ in profile 200. In other embodiments, W₂ can be equal to or less than W₁.

Assembling elongate member 204, fixed member 206 and adjustment member 208 to the tip 110 can be performed in a variety of different manners. In one embodiment, the tip 110 forms a central lumen to receive the elongate member 204 therein and a corresponding distal end recess to receive the adjustment member 208 therein. A proximal end of the elongate member 204 can be inserted into the central lumen and coupled with the profile actuator 150. The adjustment member 208 seats within the distal end recess such that the elongate member 204, adjustment member 208 and tip end 212 are in fixed relation relative to one another. The fixed member 206 can be formed integrally with the tip 110 or formed as a separate component, for example integral with a distal end of the capsule 40 or a separate component otherwise coupled to the base end 210 of the tip 110. Regardless of a particular construction for the fixed member 206, the elongate member 204, adjustment member 208 and tip end 212 are all movable with respect to the fixed member 206. In particular, a pulling force on a proximal end of the elongate member 204 will cause the base end 210 of the tip 110 to act against the fixed member 206. With enough pulling force, the tip end 212 (along with the adjustment member 208) moves toward the fixed member 206, causing compression of the tip 110. As such, the tip 110 is altered from the first profile 200 to the second profile 202. In an alternative embodiment, as discussed above, a pushing force can also be utilized to alter the tip 110 from the first profile 200 to the second profile 202.

Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure. 

What is claimed is:
 1. A device component for a prosthetic heart valve delivery system, the component comprising: an elongate member extending from a proximal end to a distal end; a tip coupled with the distal end of the elongate member and transitioning, in response to an axially applied force applied to the elongate member, from a first, conical profile to a second, rounded profile.
 2. The device component of claim 1, wherein the tip is formed of a polymeric material, the first profile defining a natural arrangement of the polymeric material and the second profile defining a compressed arrangement for the polymeric material.
 3. The device component of claim 1, wherein the tip includes a base end and a tip end opposite the base end, said axially applied force moving the tip end toward the base end.
 4. The device component of claim 1, wherein the tip is formed of a solid, homogenous structure.
 5. The device component of claim 1, wherein the tip defines a central lumen receiving the elongate member.
 6. The device component of claim 1, wherein the tip defines a base end and a tip end opposite the base end, the first profile defining a first width defined by a maximum distance of the tip orthogonal to a length of the tip from the base end to the tip end, the second profile defining a second width defined by a maximum distance of the tip orthogonal to the length of the tip that is greater than the first width.
 7. The device component of claim 1, wherein the tip defines a length extending from a base end to a tip end opposite the base end, the length of the tip in the first profile being greater than the length of the tip in the second profile.
 8. The device component of claim 1, further comprising a fixed member coupled to a base end of the tip and an adjustment member coupled to a tip end of the tip opposite the base end, said axially applied force causing movement of the adjustment member relative to the fixed member.
 9. A delivery system for a stent frame, the delivery system comprising: a retention member including a coupling structure configured to couple the frame to the retention member and a tip positioned distal the coupling structure; a capsule configured to maintain the frame in a compressed arrangement; and a tip profile control assembly including an elongate member coupled with the tip, the elongate member extending from a proximal end to a distal end, the tip including a tip end and a base end opposite the tip end, the elongate member transitioning the tip from a first profile to a second profile based on a relative position of the elongate member with respect to the base end.
 10. The delivery system of claim 9, wherein the tip profile control assembly includes a fixed member coupled to the base end and an adjustment member coupled to the tip end, the fixed member maintaining the base end in a position relative to the capsule as the adjustment member moves with respect to the base end.
 11. The delivery system of claim 9, further comprising: a handle including a housing connected to the tip profile control assembly, the handle maintaining an actuator for moving the elongate member relative to the base end.
 12. The delivery system of claim 9, wherein the tip is formed of a polymeric material.
 13. The delivery system of claim 9, wherein the tip is formed of a solid, homogenous structure.
 14. The delivery system of claim 9, wherein the tip defines a central lumen receiving the elongate member.
 15. The delivery system of claim 9, wherein the capsule includes a first capsule portion and a second capsule portion, each capsule positionable with respect to one another to release the frame from the retention member.
 16. A method of deploying a prosthetic heart valve to an implantation site, the method comprising: receiving a delivery system having a proximal handle and a distal tip, the system loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery system including a delivery sheath capsule containing the prosthetic heart valve in a compressed arrangement over an inner shaft assembly; delivering the prosthetic heart valve in the compressed arrangement through a native valve of the patient and to the implantation site via the delivery system while the tip defines a first, tapered profile; transitioning the tip from the first profile to a second, rounded profile; and adjusting a position of the delivery sheath capsule such that the prosthetic heart valve can expand to an expanded arrangement.
 17. The method of claim 16, wherein delivering the prosthetic heart valve further comprises dilating an access site while the tip end is in the first shape.
 18. The method of claim 16, further comprising: retracting the delivery system from the implantation site while the tip is in the second profile.
 19. The method of claim 16, wherein transitioning the tip from the first profile to the second profile includes compressing the tip from a natural arrangement to a compressed arrangement.
 20. The method of claim 16, wherein transitioning the tip from the first profile to the second profile includes reducing a length of the tip from a base end to a tip end.
 21. The method of claim 16, wherein transitioning the tip end from the first profile to the second profile includes operating an actuator maintained by a handle of the delivery system.
 22. The method of claim 16, wherein adjusting the position of the delivery sheath capsule includes positioning a first capsule portion to release a first portion of the prosthetic heart valve on a first side of the native valve and positioning a second capsule portion to release a second portion of the prosthetic heart valve on a second side of the native valve, opposite the first side. 